A Novel TMS Target for Anxiety: a Confirmatory Randomized Clinical Trial
Brigham and Women's Hospital
Summary
We will perform a randomized sham-controlled trial of aiTBS to an anxiosomatic circuit in patients with anxiety-related disorders (i.e., panic disorder, generalized anxiety disorder, social anxiety disorder, obsessive-compulsive disorder, and post-traumatic stress disorder). 80 participants with an anxiety-related disorder (defined below) will receive 50 active or sham TMS treatments over 5 days (following the SAINT protocol, which is FDA-cleared for MDD. The primary outcome will be the BAI, with a modified recall window to reflect the short treatment interval. Participants randomized to sham will be offered an open-label crossover extension.
Description
We recently derived a novel TMS target for anxiety via lesion and brain stimulation mapping methods. We prospectively tested this target in a sample of participants with major depressive disorder (MDD) with comorbid anxiety symptoms and found that it was more effective for anxiety (median change 60.0% vs 39.8%, p=0.01) than the conventional TMS target for MDD with comorbid anxiety. While these results are promising, it remains unclear how our target works for anxiety-related disorders as opposed to MDD comorbid anxiety symptoms. Furthermore, we used conventional 10 Hz TMS, but accelerated inte…
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * English proficiency sufficient for informed consent, questionnaires/tasks, and treatment * Diagnosis of one of the following anxiety-related disorders per Quick-SCID: * Generalized Anxiety Disorder * Social Anxiety Disorder * Panic Disorder * Posttraumatic Stress Disorder * Obsessive Compulsive Disorder * Moderate level of anxiety (BAI \>16) * One failed psychological or pharmacological treatment * Stable psychiatric medication regimen for 4 weeks prior to treatment and throughout treatment * Primary clinician (e.g. psychiatrist, psychologist, therapist, APRN,…
Interventions
- ProcedureTranscranial magnetic stimulation
Transcranial magnetic stimulation (TMS) is a focal, non-invasive form of brain stimulation that has FDA clearance for depression. In this study, a form of TMS called accelerated intermittent theta burst stimulation will be administered under the supervision of a physician with TMS expertise.
- ProcedureSham transcranial magnetic stimulation
The sham TMS coil mimics the scalp sensation of real TMS by delivering a small amount of electrical current with a pair of surface electrodes.
Location
- Emma JonesBoston, Massachusetts